ABSTRACT Hydroxypropyl-guar (HPG) is a thickening agent first added to lubricating eye drops in 2... more ABSTRACT Hydroxypropyl-guar (HPG) is a thickening agent first added to lubricating eye drops in 2003. This agent, which enhances viscosity, has been used in the SYSTANE® family of lubricant eye drops (Alcon Laboratories, Inc., Fort Worth, TX, USA). HPG forms a partially linked gel with borate to prolong the retention of demulcents, such as polyethylene glycol and propylene glycol, on the eye. This helps to protect the ocular surface, thereby reducing the symptoms of dry eye disease (DED). The definition of DED has evolved with advances in research, leading to changes in HPG-containing eye care solutions. This article reviews current knowledge on the use of HPG-containing lubricating eye drops in the management of DED.
Abstract Purpose: : Silicone hydrogel (SiH) lenses can cause contact lens induced conjunctival st... more Abstract Purpose: : Silicone hydrogel (SiH) lenses can cause contact lens induced conjunctival staining (CLICS) in some patients. CLICS may be induced by the higher modulus or unique surface characteristics of SiH lenses, changes in lens parameters during wear, or other factors such as poor lens fit or poor edge design. Three studies evaluated the impact of contact lenses and solutions on conjunctival staining and lens parameters Methods: : 1) Lissamine green was utilized to systematically identify a lens and solution combination that minimized CLICS in ten patients. Base curve, lens material, or solution was changed to determine the influence of each on CLICS. 2) The base curves of SiH lenses (senofilcon A) were measured following one or two weeks of wear using OPTI-FREE® RepleniSH® or Clear Care®. Recovery of base curves over time and the effect of temperature on the recovery (separate in vitro experiments) were measured. 3) A randomized, investigator-masked, crossover study was conducted (n= 25) wearing SiH lenses (senofilcon A; 8.4 BC) cared for with ReNu MultiPlus®, Complete® EasyRub or Clear Care® for one week each. Lens fit, lens parameters, corneal curvature, and corneal and conjunctival staining were assessed. Results: : 1) CLICS was observed in all ten patients with their habitual lenses and solutions even though the fit had been considered acceptable. Changing the lens material or base curve, but not the solution, impacted the amount of CLICS. 2) Base curves were steepened to 7.9 to 8.2 after one week of wear independent of solution. Base curves returned to baseline within a few hours of lens removal for both solutions. The base curve changes and recovery are influenced by temperature. 3) Preliminary data indicate that base curve and corneal curvature change following one week of wear. CLICS occurs frequently with the test lenses and may not be influenced by solution. Conclusions: : This series of studies indicates that SiH lenses can induce CLICS. This staining may be the result of changes in lens parameters over time as lenses are worn. It is important that practitioners use lissamine green to evaluate CLICS to better assess lens fit to optimize ocular health. Clinical Trial: : www.clinicaltrials.gov NCT00799422
CLEAR CARE PLUS (CCP), also known as AOSEPT PLUS with HydraGlyde, is approved for use with gas pe... more CLEAR CARE PLUS (CCP), also known as AOSEPT PLUS with HydraGlyde, is approved for use with gas permeable (GP) lenses, and the indication is supported by the scientific evidence that is reviewed in this article. Antimicrobial efficacy testing of CCP both as a stand-alone disinfectant and as part of a regimen shows that CCP exceeds the ISO 14729 criteria against bacteria, yeast, and mold. In real-world conditions, it is effective against clinically relevant bacterial strains isolated from adverse events and against the two forms, trophozoites and cysts, of resilient Acanthamoeba species. Compatibility tests of CCP with two types of GP lenses indicate that the physical and/or optical parameters of lenses are unaffected through 30 cycles of simulated use with CCP, and a clinical trial shows substantial equivalence of clinical performance with a commonly used GP multipurpose solution. These results indicate that CCP is well suited for cleaning and disinfection of GP contact lenses.
The purpose was to compare the effect of the repeated usage of two care systems (one hydrogen per... more The purpose was to compare the effect of the repeated usage of two care systems (one hydrogen peroxide cleaning and disinfecting system and one polyaminopropyl biguanide (PHMB) containing multipurpose system) with silicone hydrogel contact lenses worn for three months on a daily wear modality. A specific aspect of interest was of the effect of the care systems on contact lens wettability. Methods: Seventy-four symptomatic contact lens wearers, habitually wearing either ACUVUE 1 OASYS 1 (n = 37) or PureVision TM (n = 37), constituted the study population. The study was a two-arm prospective, investigator-masked, bilateral study of three-month duration to evaluate the effects of CLEAR CARE 1 compared with renu 1 fresh TM. The subjects were randomized to one of the two lens care systems. Contact lens wettability and surface cleanliness were assessed with the Tearscope and reported in terms of pre-lens non-invasive break-up time (PL-NIBUT) and visible deposits. Baseline assessments at enrollment were with the subjects' own contact lenses worn for at least 6 h when using their habitual PHMB-preserved care system and at the dispensing visit with new contact lenses. At the follow-up visits, the contact lenses were worn for at least 6 h, and were at least 11 days old for ACUVUE 1 OASYS 1 and 25 days old for PureVision TM. Results: The results obtained showed that: (i) with CLEAR CARE 1 , a significant improvement in contact lens wettability was recorded compared with the habitual care system at the three-month follow-up visit (mean median PL-NIBUT 5.8 vs. 4.0 s, p < 0.001). Further, with this same lens care system a significant increase in wettability was observed at the three-month follow-up visit compared with dispensing (mean median PL-NIBUT 5.8 vs. 4.5 s, p = 0.022). (ii) Whereas no difference in contact lens wettability was observed at dispensing between the two lens care groups (mean PL-NIBUT: 4.5 vs. 4.2 s, p = 0.518), a significantly more stable pre-lens tear film was observed with CLEAR CARE 1 than with renu 1 fresh TM at both the two-month (mean PL-NIBUT: 4.6 vs. 3.7 s, p = 0.005) and three-month (mean PL-NIBUT: 5.8 vs. 4.2 s, p = 0.028) visits. iii. With renu 1 fresh TM , no significant differences were observed at the end of three months of use compared with either the habitual care system or the new contact lens solution (mean PL-NIBUT: 3 M 4.2 vs. Disp 4.2 s (p = 0.420) vs. enrolment habitual care solution 5.1 s (p = 0.734)). iv. With CLEAR CARE 1 significant increases in the incidence of surfaces free of both mucus (3 month 95%. vs. habitual solution 82% enrolment; p = 0.005) and lipid (3 month 87% vs. habitual solution 72% enrolment; p = 0.009) were observed. Conclusion: Significantly better contact lens wettability and surface cleanliness were achieved for ACUVUE 1 OASYS 1 and PureVision TM with CLEAR CARE 1 than with renu 1 fresh TM at the end of three months of use. 2015 British Contact Lens Association. Published by Elsevier Ltd.
Optometry and vision science : official publication of the American Academy of Optometry, 2014
The purpose of the study was to measure contact lens lipid spoliation of silicone hydrogel PureVi... more The purpose of the study was to measure contact lens lipid spoliation of silicone hydrogel PureVision (balafilcon A) and hydrogel Acuvue 2 (etafilcon A) contact lenses worn for 10 hours single use (DD) and 7 days of extended wear (EW). Two similar study populations (DD, n = 55; EW, n = 53), were enrolled at four study sites. In each population, a bilateral, randomized, crossover (lens material), subject-masked experimental design was followed. Worn contact lenses were analyzed for lipid uptake using high-performance liquid chromatography by two laboratories: Alcon Laboratories (right lens total uptake) and OTG Research & Consultancy (left lens total uptake and individual lipid classes). Lipid uptake was different for the two materials: total lipid (p < 0.007), cholesterol esters (p < 0.001), cholesterol (p < 0.001 EW only), and triglycerides/phospholipids (p < 0.001) were higher for balafilcon A, whereas fatty acid (p < 0.0025 EW only) was higher for etafilcon A. The ...
Prosthetic contact lenses grovide an important therapeutic tool in the treatment of diseased and ... more Prosthetic contact lenses grovide an important therapeutic tool in the treatment of diseased and disfigured eyes. This article discusses general clinical fitting considerations of prosthetic knses and highlights the use of a newly available opaque hydrogel prosthetic lens for a 27-year-old Hispanic female with a decompensated cornea secondary to four failed keratoplasties.
Optometry - Journal of the American Optometric Association, 2004
ferent contact lens materials and disinfection products were tested in short-term clinical studie... more ferent contact lens materials and disinfection products were tested in short-term clinical studies to determine the degree of ocular signs and symptoms observed over a period of 1 to 6 hours after lens insertion. Results: Uptake of PHMB after 10 cycles was as high as 7.2 pgllens for crofilcon A, followed by 5.7 pgllens for omafilcon A material. The uptake profile was dependent on PHMB concentration and the type of lens material. PQ uptake was below the detection limit of 1 pgllens for all materials. Zone-of-inhibition results indicated that products containing 1 ppm PHMB in combination with crofilcon A lens material caused the largest zones-of-inhibition, followed by methafilcon A and omafilcon A. A dose response behavior was observed for products with lower concentrations of PHMB. These pre-clinical results were confirmed in clinical studies. Combinations of lens materials with products containing 1 ppm PHMB caused diffuse punctuate staining for up to 6 hours after instillation for several lenslsolution combinations. Ocular discomfort was sometimes associated with the more-sigmficant levels of staining. No significant staining was observed with the PQ-containing product for any of the lens materials. Conclusion: Pre-clinical tests based on lens uptake and zone-of-inhibition methodologies are good indicators of potential clinical incompatibilities between lens materials and disinfection products.
Optometry - Journal of the American Optometric Association, 2005
Purpose: The purpose of this poster is to determine if the interactions of lens care preservative... more Purpose: The purpose of this poster is to determine if the interactions of lens care preservatives with contact lenses is an important factor in clinical signs and symptoms. Methods: This study evaluated uptake and release profiles of three preservatives used in MPS products: alexidine contained in ReNu" with MoistureLoc@; polyhexanide (PHMB) contained in Aquifym; and POLYQUADB (polyquaternium-1) contained in Opti-Freem Expressm. Three lens materials were used in a cross over study design: SofLensm 66, Acuvue" 2 and Acuvue" AdvanceTM. The worn lenses were analyzed for preservative content using HPLC and release profiles were calculated. Shortterm changes in corneal staining and ocular symptoms were assessed at defined time intervals following lens insertion in order to compare these ocular findings with laboratory uptake and release properties. Results: After 2 hours, Acuvue" 2 and SofLensm 66 released 67% and 78% of alexidine, respectively. Acuvuea Advance" released 29% of the preservative in two hours. The results show PHMB uptake into AcuvueP 2 and SofLensm 66 lenses when soaked in AQuify@ MPS for 6, 10, and 30 cycles. Clinically significant corneal staining was observed at 2 and 4 hours when subjects wore Acuvuem 2 and Acuvuem Advance" lenses soaked in the alexidine-based system. At the 2-hour interval, extent of corneal staining increased in all subjects with Acuvuee 2 lenses, and 50% of the subjects with Acuvue" Advance" lenses. Only minimal staining was observed for SofLensm 66 at 2, 4, and 6 hours. Symptoms were not correlated with the extent of staining. Lenses cycled in the POLYQUADB-based product showed minimal uptake into lenses, and corneal staining was low with all the lens materials tested. Conclusions: The study demonstrated the difference in uptakelrelease profiles for MPS products preserved with alexidine, PHMB, or POLYQUAD" using three soft lens materials.
Optometry - Journal of the American Optometric Association, 2006
PURPOSE: To determine the ocular response associated with various combinations of silicone hydrog... more PURPOSE: To determine the ocular response associated with various combinations of silicone hydrogel lenses and marketed multipurpose solutions (MPS) based on comfort and corneal staining after 2 and 4 hrs of lens wear. METHODS: A series of clinical studies was conducted at one research site, using a double-masked, randomized, crossover design. Nine to 14 asymptomatic soft contact lens wearers wore silicone hydrogel lenses for 2 and 4 hrs. Prior to wear, new lenses were presoaked in Alcon OPTI-FREE® EXPRESS® (polyquaternium-1), B&L ReNu® MoistureLoc® (alexidine), CIBA Vision AQuify® (polyhexanide), or AMO Complete® MoisturePLUS™ (polyhexamethylene biguanide) for 12 hrs. in a preconditioned lens case. At baseline, 2-hr, and 4-hr visits on the same day, subjects rated comfort and the cornea was examined with fluorescein and a yellow filter. Staining severity (0-4) and area (0-100%) were recorded for five corneal zones per eye. RESULTS: All observed staining type was micropunctate. The combinations with the greatest staining area were Complete MoisturePLUS/ PureVision at 2 hrs (38%) and 4 hrs (33.7%), AQuify/PureVision at 2 hrs (21.3%) and 4 hrs (11.7%), MoistureLoc/Oasys at 4 hrs (8.2%), MoistureLoc/PureVision at 4 hrs (8%), MoistureLoc/O 2 Optix at 4 hrs (7.4%), and AQuify/O 2 Optix at 2 hrs (7.1%). OPTI-FREE® EXPRESS® caused minimal staining, averaging 3.5% at 2 hrs and 3.8% at 4 hrs across all lens brands. Comfort ratings and staining area results were inversely correlated (r =-0.44) at the 4 hr visit. Additional combinations of marketed lenses and MPS are currently being evaluated for corneal staining. CONCLUSIONS: These results demonstrate how certain combinations of silicone hydrogel lenses and MPS may cause clinically meaningful corneal staining within 2-4 hours. Practitioners who dispense these lens materials and solutions should be aware of the potential ocular response and consider examining the patient in the first few hours after lens insertion.
Optometry - Journal of the American Optometric Association, 2009
medically treated events (R 5 3 eyes/ 0.26% and OF 5 14 eyes/ 1.21%), P 5 0.007. Analysis of medi... more medically treated events (R 5 3 eyes/ 0.26% and OF 5 14 eyes/ 1.21%), P 5 0.007. Analysis of medically treated events possibly related to the solution determined that there were significantly fewer events related to R (R 5 0 eyes/ 0.00% and OF 5 8 eyes/ 0.69%), P 5 0.004. Conclusion: The meta-analysis confirmed that there were few significant medical events associated with the use of silicone hydrogel lenses and the 2 lens care product families evaluated in the combined studies. The meta-analysis also provided a useful tool to understand the relationships between the 2 lens care product families and infrequent, yet significant, medical events. Silicone hydrogel patients who used a polyaminopropyl-biguanide family (R) had fewer discontinuations due to positive slit lamp findings, medically treated events and medically treated events possibly related to the solution than silicone hydrogel patients who used a family of Polyquad/Aldox preserved multipurpose solutions (OF).
Journal of the American Pharmacists Association, 2004
Objective: To examine patients' perceptions on the relative importance of the physical characteri... more Objective: To examine patients' perceptions on the relative importance of the physical characteristics and appearance of dietary supplements, and to evaluate two supplements with the same combination of vitamins and minerals used in the Age-Related Eye Disease Study (AREDS) with respect to ease of swallowing and other features in elderly patients. Design: A single-site, single-visit, crossover design, subject-masked comparison of two dietary supplements (ICaps AREDS Formula-Alcon; Ocuvite PreserVision-Bausch & Lomb). Setting: Ophthalmology practice. Patients: 50 patients aged 50 years or older. Interventions: Patients ranked the importance of eight physical characteristics of a vitamin tablet or capsule (ease of swallowing, size, shape, color, smell, coating, texture, and taste) irrespective of the test products used in the study and then took both test products randomly and were asked to indicate which product they preferred based on the same eight characteristics. Main Outcome Measures: Overall patient preference and preference for swallowing two tablets at once. Results: The highest rated (most important) characteristic in a vitamin supplement was ease of swallowing, with a median score of 9.0 on a 0-10 visual analogue scale. The characteristic of least importance was tablet color, with the lowest median score of 1.0. Statistically significant differences were detected between the products with regard to preferences for ease of swallowing, swallowing two tablets at once, size, and coating (P ≤ .0001). Significantly more patients preferred the ICaps AREDS formula to Ocuvite PreserVision with respect to these characteristics and overall preference (P < .001). Age, gender, and previous vitamin use were contributing factors in the rating of physical characteristics and tablet preferences. Conclusion: Based on the results of this study, ease of swallowing is the most important characteristic of dietary supplement tablets for elderly patients, followed by taste, size, and smell. Significant differences in preference exist between the study products, which contain similar formulations but have different physical characteristics.
Eye & Contact Lens: Science & Clinical Practice, 2012
The principal objective of the study was to measure the conjunctival staining produced in the cir... more The principal objective of the study was to measure the conjunctival staining produced in the circumlimbal region by silicone hydrogel contact lenses with different edge designs. The secondary objective was to investigate the association between circumlimbal staining and comfort. Methods: Four silicone hydrogel contact lenses: ACUVUE OASYS (knife edge design), AIR OPTIX, Biofinity (chisel edge rounded edge combination), and PureVision (rounded edge design), and 1 hydrogel contact lens, ACUVUE 2 (knife edge design), were tested. The study was conducted on a cohort population of 27 established soft contact lens wearers, who wore each contact lens type, in a random order, for a period of 10 (62) days. Circumlimbal staining was measured in a double-masked fashion through image analysis of digital photographs of lissamine green taken under controlled experimental conditions. Results: The results obtained showed that contact lens edge design was the primary factor controlling circumlimbal staining for silicone hydrogel lenses: a rounded edge away from the ocular surface produced the lowest staining (average, 0.19%) and a knife edge in close apposition to the ocular surface produced the highest staining (average, 1.34%). Contact lens material rigidity was also identified to affect circumlimbal staining and an inverse association between circumlimbal staining and contact lens comfort was demonstrated: the rounded edge design produced the lowest comfort (72 of 100) and the knife edge design produced the highest (87 out of 100). Conclusion: Soft contact lens wear induces circumlimbal staining, the level of staining being influenced by the contact lens edge design. However, high level of circumlimbal staining is not associated with decreased comfort.
Eye & Contact Lens: Science & Clinical Practice, 2005
Purpose. Short-term changes in corneal staining and ocular symptoms were assessed at defined inte... more Purpose. Short-term changes in corneal staining and ocular symptoms were assessed at defined intervals to evaluate combinations of three soft lenses and four multipurpose solutions. Methods. A series of pilot studies were conducted over 11 months using a double-masked, randomized, crossover design. Asymptomatic, adapted, daily-wear soft lens users wore group II or IV soft hydrophilic or silicone hydrogel lenses for a maximum period each day. Before wear, new lenses were soaked overnight in one of four multipurpose solutions: Alcon OPTI-FREE Express MPDS, Bausch & Lomb ReNu MultiPlus Multipurpose Solution, CIBA Vision SOLO-Care PLUS Multipurpose Solution, or AMO Complete MoisturePLUS. Subjects rated comfort and ocular symptoms. Corneal staining type and area were evaluated at baseline and after lens removal. Results. Significantly increased extent of corneal staining, defined as the proportion of corneal zones showing staining of grade 1 or more severe, was observed at 1 and 2 hours when subjects wore group II lenses soaked in the polyhexamethylene biguanide-based systems. Significantly increased extent of staining was observed at 2 hours when subjects used silicone hydrogel lenses soaked in regimen 4. When subjects used regimen 1 and wore group II lenses, only a minimal staining response was observed at 1 and 2 hours of wear. Significant symptoms were not correlated with extent of staining. Conclusions. This study design is a promising tool that can discriminate between the performance of different soft lens and multipurpose solution combinations rapidly using small patient samples. With some lens-care product combinations, corneal appearance may vary according to the time of day the patient is examined.
ABSTRACT Hydroxypropyl-guar (HPG) is a thickening agent first added to lubricating eye drops in 2... more ABSTRACT Hydroxypropyl-guar (HPG) is a thickening agent first added to lubricating eye drops in 2003. This agent, which enhances viscosity, has been used in the SYSTANE® family of lubricant eye drops (Alcon Laboratories, Inc., Fort Worth, TX, USA). HPG forms a partially linked gel with borate to prolong the retention of demulcents, such as polyethylene glycol and propylene glycol, on the eye. This helps to protect the ocular surface, thereby reducing the symptoms of dry eye disease (DED). The definition of DED has evolved with advances in research, leading to changes in HPG-containing eye care solutions. This article reviews current knowledge on the use of HPG-containing lubricating eye drops in the management of DED.
Abstract Purpose: : Silicone hydrogel (SiH) lenses can cause contact lens induced conjunctival st... more Abstract Purpose: : Silicone hydrogel (SiH) lenses can cause contact lens induced conjunctival staining (CLICS) in some patients. CLICS may be induced by the higher modulus or unique surface characteristics of SiH lenses, changes in lens parameters during wear, or other factors such as poor lens fit or poor edge design. Three studies evaluated the impact of contact lenses and solutions on conjunctival staining and lens parameters Methods: : 1) Lissamine green was utilized to systematically identify a lens and solution combination that minimized CLICS in ten patients. Base curve, lens material, or solution was changed to determine the influence of each on CLICS. 2) The base curves of SiH lenses (senofilcon A) were measured following one or two weeks of wear using OPTI-FREE® RepleniSH® or Clear Care®. Recovery of base curves over time and the effect of temperature on the recovery (separate in vitro experiments) were measured. 3) A randomized, investigator-masked, crossover study was conducted (n= 25) wearing SiH lenses (senofilcon A; 8.4 BC) cared for with ReNu MultiPlus®, Complete® EasyRub or Clear Care® for one week each. Lens fit, lens parameters, corneal curvature, and corneal and conjunctival staining were assessed. Results: : 1) CLICS was observed in all ten patients with their habitual lenses and solutions even though the fit had been considered acceptable. Changing the lens material or base curve, but not the solution, impacted the amount of CLICS. 2) Base curves were steepened to 7.9 to 8.2 after one week of wear independent of solution. Base curves returned to baseline within a few hours of lens removal for both solutions. The base curve changes and recovery are influenced by temperature. 3) Preliminary data indicate that base curve and corneal curvature change following one week of wear. CLICS occurs frequently with the test lenses and may not be influenced by solution. Conclusions: : This series of studies indicates that SiH lenses can induce CLICS. This staining may be the result of changes in lens parameters over time as lenses are worn. It is important that practitioners use lissamine green to evaluate CLICS to better assess lens fit to optimize ocular health. Clinical Trial: : www.clinicaltrials.gov NCT00799422
CLEAR CARE PLUS (CCP), also known as AOSEPT PLUS with HydraGlyde, is approved for use with gas pe... more CLEAR CARE PLUS (CCP), also known as AOSEPT PLUS with HydraGlyde, is approved for use with gas permeable (GP) lenses, and the indication is supported by the scientific evidence that is reviewed in this article. Antimicrobial efficacy testing of CCP both as a stand-alone disinfectant and as part of a regimen shows that CCP exceeds the ISO 14729 criteria against bacteria, yeast, and mold. In real-world conditions, it is effective against clinically relevant bacterial strains isolated from adverse events and against the two forms, trophozoites and cysts, of resilient Acanthamoeba species. Compatibility tests of CCP with two types of GP lenses indicate that the physical and/or optical parameters of lenses are unaffected through 30 cycles of simulated use with CCP, and a clinical trial shows substantial equivalence of clinical performance with a commonly used GP multipurpose solution. These results indicate that CCP is well suited for cleaning and disinfection of GP contact lenses.
The purpose was to compare the effect of the repeated usage of two care systems (one hydrogen per... more The purpose was to compare the effect of the repeated usage of two care systems (one hydrogen peroxide cleaning and disinfecting system and one polyaminopropyl biguanide (PHMB) containing multipurpose system) with silicone hydrogel contact lenses worn for three months on a daily wear modality. A specific aspect of interest was of the effect of the care systems on contact lens wettability. Methods: Seventy-four symptomatic contact lens wearers, habitually wearing either ACUVUE 1 OASYS 1 (n = 37) or PureVision TM (n = 37), constituted the study population. The study was a two-arm prospective, investigator-masked, bilateral study of three-month duration to evaluate the effects of CLEAR CARE 1 compared with renu 1 fresh TM. The subjects were randomized to one of the two lens care systems. Contact lens wettability and surface cleanliness were assessed with the Tearscope and reported in terms of pre-lens non-invasive break-up time (PL-NIBUT) and visible deposits. Baseline assessments at enrollment were with the subjects' own contact lenses worn for at least 6 h when using their habitual PHMB-preserved care system and at the dispensing visit with new contact lenses. At the follow-up visits, the contact lenses were worn for at least 6 h, and were at least 11 days old for ACUVUE 1 OASYS 1 and 25 days old for PureVision TM. Results: The results obtained showed that: (i) with CLEAR CARE 1 , a significant improvement in contact lens wettability was recorded compared with the habitual care system at the three-month follow-up visit (mean median PL-NIBUT 5.8 vs. 4.0 s, p < 0.001). Further, with this same lens care system a significant increase in wettability was observed at the three-month follow-up visit compared with dispensing (mean median PL-NIBUT 5.8 vs. 4.5 s, p = 0.022). (ii) Whereas no difference in contact lens wettability was observed at dispensing between the two lens care groups (mean PL-NIBUT: 4.5 vs. 4.2 s, p = 0.518), a significantly more stable pre-lens tear film was observed with CLEAR CARE 1 than with renu 1 fresh TM at both the two-month (mean PL-NIBUT: 4.6 vs. 3.7 s, p = 0.005) and three-month (mean PL-NIBUT: 5.8 vs. 4.2 s, p = 0.028) visits. iii. With renu 1 fresh TM , no significant differences were observed at the end of three months of use compared with either the habitual care system or the new contact lens solution (mean PL-NIBUT: 3 M 4.2 vs. Disp 4.2 s (p = 0.420) vs. enrolment habitual care solution 5.1 s (p = 0.734)). iv. With CLEAR CARE 1 significant increases in the incidence of surfaces free of both mucus (3 month 95%. vs. habitual solution 82% enrolment; p = 0.005) and lipid (3 month 87% vs. habitual solution 72% enrolment; p = 0.009) were observed. Conclusion: Significantly better contact lens wettability and surface cleanliness were achieved for ACUVUE 1 OASYS 1 and PureVision TM with CLEAR CARE 1 than with renu 1 fresh TM at the end of three months of use. 2015 British Contact Lens Association. Published by Elsevier Ltd.
Optometry and vision science : official publication of the American Academy of Optometry, 2014
The purpose of the study was to measure contact lens lipid spoliation of silicone hydrogel PureVi... more The purpose of the study was to measure contact lens lipid spoliation of silicone hydrogel PureVision (balafilcon A) and hydrogel Acuvue 2 (etafilcon A) contact lenses worn for 10 hours single use (DD) and 7 days of extended wear (EW). Two similar study populations (DD, n = 55; EW, n = 53), were enrolled at four study sites. In each population, a bilateral, randomized, crossover (lens material), subject-masked experimental design was followed. Worn contact lenses were analyzed for lipid uptake using high-performance liquid chromatography by two laboratories: Alcon Laboratories (right lens total uptake) and OTG Research & Consultancy (left lens total uptake and individual lipid classes). Lipid uptake was different for the two materials: total lipid (p < 0.007), cholesterol esters (p < 0.001), cholesterol (p < 0.001 EW only), and triglycerides/phospholipids (p < 0.001) were higher for balafilcon A, whereas fatty acid (p < 0.0025 EW only) was higher for etafilcon A. The ...
Prosthetic contact lenses grovide an important therapeutic tool in the treatment of diseased and ... more Prosthetic contact lenses grovide an important therapeutic tool in the treatment of diseased and disfigured eyes. This article discusses general clinical fitting considerations of prosthetic knses and highlights the use of a newly available opaque hydrogel prosthetic lens for a 27-year-old Hispanic female with a decompensated cornea secondary to four failed keratoplasties.
Optometry - Journal of the American Optometric Association, 2004
ferent contact lens materials and disinfection products were tested in short-term clinical studie... more ferent contact lens materials and disinfection products were tested in short-term clinical studies to determine the degree of ocular signs and symptoms observed over a period of 1 to 6 hours after lens insertion. Results: Uptake of PHMB after 10 cycles was as high as 7.2 pgllens for crofilcon A, followed by 5.7 pgllens for omafilcon A material. The uptake profile was dependent on PHMB concentration and the type of lens material. PQ uptake was below the detection limit of 1 pgllens for all materials. Zone-of-inhibition results indicated that products containing 1 ppm PHMB in combination with crofilcon A lens material caused the largest zones-of-inhibition, followed by methafilcon A and omafilcon A. A dose response behavior was observed for products with lower concentrations of PHMB. These pre-clinical results were confirmed in clinical studies. Combinations of lens materials with products containing 1 ppm PHMB caused diffuse punctuate staining for up to 6 hours after instillation for several lenslsolution combinations. Ocular discomfort was sometimes associated with the more-sigmficant levels of staining. No significant staining was observed with the PQ-containing product for any of the lens materials. Conclusion: Pre-clinical tests based on lens uptake and zone-of-inhibition methodologies are good indicators of potential clinical incompatibilities between lens materials and disinfection products.
Optometry - Journal of the American Optometric Association, 2005
Purpose: The purpose of this poster is to determine if the interactions of lens care preservative... more Purpose: The purpose of this poster is to determine if the interactions of lens care preservatives with contact lenses is an important factor in clinical signs and symptoms. Methods: This study evaluated uptake and release profiles of three preservatives used in MPS products: alexidine contained in ReNu" with MoistureLoc@; polyhexanide (PHMB) contained in Aquifym; and POLYQUADB (polyquaternium-1) contained in Opti-Freem Expressm. Three lens materials were used in a cross over study design: SofLensm 66, Acuvue" 2 and Acuvue" AdvanceTM. The worn lenses were analyzed for preservative content using HPLC and release profiles were calculated. Shortterm changes in corneal staining and ocular symptoms were assessed at defined time intervals following lens insertion in order to compare these ocular findings with laboratory uptake and release properties. Results: After 2 hours, Acuvue" 2 and SofLensm 66 released 67% and 78% of alexidine, respectively. Acuvuea Advance" released 29% of the preservative in two hours. The results show PHMB uptake into AcuvueP 2 and SofLensm 66 lenses when soaked in AQuify@ MPS for 6, 10, and 30 cycles. Clinically significant corneal staining was observed at 2 and 4 hours when subjects wore Acuvuem 2 and Acuvuem Advance" lenses soaked in the alexidine-based system. At the 2-hour interval, extent of corneal staining increased in all subjects with Acuvuee 2 lenses, and 50% of the subjects with Acuvue" Advance" lenses. Only minimal staining was observed for SofLensm 66 at 2, 4, and 6 hours. Symptoms were not correlated with the extent of staining. Lenses cycled in the POLYQUADB-based product showed minimal uptake into lenses, and corneal staining was low with all the lens materials tested. Conclusions: The study demonstrated the difference in uptakelrelease profiles for MPS products preserved with alexidine, PHMB, or POLYQUAD" using three soft lens materials.
Optometry - Journal of the American Optometric Association, 2006
PURPOSE: To determine the ocular response associated with various combinations of silicone hydrog... more PURPOSE: To determine the ocular response associated with various combinations of silicone hydrogel lenses and marketed multipurpose solutions (MPS) based on comfort and corneal staining after 2 and 4 hrs of lens wear. METHODS: A series of clinical studies was conducted at one research site, using a double-masked, randomized, crossover design. Nine to 14 asymptomatic soft contact lens wearers wore silicone hydrogel lenses for 2 and 4 hrs. Prior to wear, new lenses were presoaked in Alcon OPTI-FREE® EXPRESS® (polyquaternium-1), B&L ReNu® MoistureLoc® (alexidine), CIBA Vision AQuify® (polyhexanide), or AMO Complete® MoisturePLUS™ (polyhexamethylene biguanide) for 12 hrs. in a preconditioned lens case. At baseline, 2-hr, and 4-hr visits on the same day, subjects rated comfort and the cornea was examined with fluorescein and a yellow filter. Staining severity (0-4) and area (0-100%) were recorded for five corneal zones per eye. RESULTS: All observed staining type was micropunctate. The combinations with the greatest staining area were Complete MoisturePLUS/ PureVision at 2 hrs (38%) and 4 hrs (33.7%), AQuify/PureVision at 2 hrs (21.3%) and 4 hrs (11.7%), MoistureLoc/Oasys at 4 hrs (8.2%), MoistureLoc/PureVision at 4 hrs (8%), MoistureLoc/O 2 Optix at 4 hrs (7.4%), and AQuify/O 2 Optix at 2 hrs (7.1%). OPTI-FREE® EXPRESS® caused minimal staining, averaging 3.5% at 2 hrs and 3.8% at 4 hrs across all lens brands. Comfort ratings and staining area results were inversely correlated (r =-0.44) at the 4 hr visit. Additional combinations of marketed lenses and MPS are currently being evaluated for corneal staining. CONCLUSIONS: These results demonstrate how certain combinations of silicone hydrogel lenses and MPS may cause clinically meaningful corneal staining within 2-4 hours. Practitioners who dispense these lens materials and solutions should be aware of the potential ocular response and consider examining the patient in the first few hours after lens insertion.
Optometry - Journal of the American Optometric Association, 2009
medically treated events (R 5 3 eyes/ 0.26% and OF 5 14 eyes/ 1.21%), P 5 0.007. Analysis of medi... more medically treated events (R 5 3 eyes/ 0.26% and OF 5 14 eyes/ 1.21%), P 5 0.007. Analysis of medically treated events possibly related to the solution determined that there were significantly fewer events related to R (R 5 0 eyes/ 0.00% and OF 5 8 eyes/ 0.69%), P 5 0.004. Conclusion: The meta-analysis confirmed that there were few significant medical events associated with the use of silicone hydrogel lenses and the 2 lens care product families evaluated in the combined studies. The meta-analysis also provided a useful tool to understand the relationships between the 2 lens care product families and infrequent, yet significant, medical events. Silicone hydrogel patients who used a polyaminopropyl-biguanide family (R) had fewer discontinuations due to positive slit lamp findings, medically treated events and medically treated events possibly related to the solution than silicone hydrogel patients who used a family of Polyquad/Aldox preserved multipurpose solutions (OF).
Journal of the American Pharmacists Association, 2004
Objective: To examine patients' perceptions on the relative importance of the physical characteri... more Objective: To examine patients' perceptions on the relative importance of the physical characteristics and appearance of dietary supplements, and to evaluate two supplements with the same combination of vitamins and minerals used in the Age-Related Eye Disease Study (AREDS) with respect to ease of swallowing and other features in elderly patients. Design: A single-site, single-visit, crossover design, subject-masked comparison of two dietary supplements (ICaps AREDS Formula-Alcon; Ocuvite PreserVision-Bausch & Lomb). Setting: Ophthalmology practice. Patients: 50 patients aged 50 years or older. Interventions: Patients ranked the importance of eight physical characteristics of a vitamin tablet or capsule (ease of swallowing, size, shape, color, smell, coating, texture, and taste) irrespective of the test products used in the study and then took both test products randomly and were asked to indicate which product they preferred based on the same eight characteristics. Main Outcome Measures: Overall patient preference and preference for swallowing two tablets at once. Results: The highest rated (most important) characteristic in a vitamin supplement was ease of swallowing, with a median score of 9.0 on a 0-10 visual analogue scale. The characteristic of least importance was tablet color, with the lowest median score of 1.0. Statistically significant differences were detected between the products with regard to preferences for ease of swallowing, swallowing two tablets at once, size, and coating (P ≤ .0001). Significantly more patients preferred the ICaps AREDS formula to Ocuvite PreserVision with respect to these characteristics and overall preference (P < .001). Age, gender, and previous vitamin use were contributing factors in the rating of physical characteristics and tablet preferences. Conclusion: Based on the results of this study, ease of swallowing is the most important characteristic of dietary supplement tablets for elderly patients, followed by taste, size, and smell. Significant differences in preference exist between the study products, which contain similar formulations but have different physical characteristics.
Eye & Contact Lens: Science & Clinical Practice, 2012
The principal objective of the study was to measure the conjunctival staining produced in the cir... more The principal objective of the study was to measure the conjunctival staining produced in the circumlimbal region by silicone hydrogel contact lenses with different edge designs. The secondary objective was to investigate the association between circumlimbal staining and comfort. Methods: Four silicone hydrogel contact lenses: ACUVUE OASYS (knife edge design), AIR OPTIX, Biofinity (chisel edge rounded edge combination), and PureVision (rounded edge design), and 1 hydrogel contact lens, ACUVUE 2 (knife edge design), were tested. The study was conducted on a cohort population of 27 established soft contact lens wearers, who wore each contact lens type, in a random order, for a period of 10 (62) days. Circumlimbal staining was measured in a double-masked fashion through image analysis of digital photographs of lissamine green taken under controlled experimental conditions. Results: The results obtained showed that contact lens edge design was the primary factor controlling circumlimbal staining for silicone hydrogel lenses: a rounded edge away from the ocular surface produced the lowest staining (average, 0.19%) and a knife edge in close apposition to the ocular surface produced the highest staining (average, 1.34%). Contact lens material rigidity was also identified to affect circumlimbal staining and an inverse association between circumlimbal staining and contact lens comfort was demonstrated: the rounded edge design produced the lowest comfort (72 of 100) and the knife edge design produced the highest (87 out of 100). Conclusion: Soft contact lens wear induces circumlimbal staining, the level of staining being influenced by the contact lens edge design. However, high level of circumlimbal staining is not associated with decreased comfort.
Eye & Contact Lens: Science & Clinical Practice, 2005
Purpose. Short-term changes in corneal staining and ocular symptoms were assessed at defined inte... more Purpose. Short-term changes in corneal staining and ocular symptoms were assessed at defined intervals to evaluate combinations of three soft lenses and four multipurpose solutions. Methods. A series of pilot studies were conducted over 11 months using a double-masked, randomized, crossover design. Asymptomatic, adapted, daily-wear soft lens users wore group II or IV soft hydrophilic or silicone hydrogel lenses for a maximum period each day. Before wear, new lenses were soaked overnight in one of four multipurpose solutions: Alcon OPTI-FREE Express MPDS, Bausch & Lomb ReNu MultiPlus Multipurpose Solution, CIBA Vision SOLO-Care PLUS Multipurpose Solution, or AMO Complete MoisturePLUS. Subjects rated comfort and ocular symptoms. Corneal staining type and area were evaluated at baseline and after lens removal. Results. Significantly increased extent of corneal staining, defined as the proportion of corneal zones showing staining of grade 1 or more severe, was observed at 1 and 2 hours when subjects wore group II lenses soaked in the polyhexamethylene biguanide-based systems. Significantly increased extent of staining was observed at 2 hours when subjects used silicone hydrogel lenses soaked in regimen 4. When subjects used regimen 1 and wore group II lenses, only a minimal staining response was observed at 1 and 2 hours of wear. Significant symptoms were not correlated with extent of staining. Conclusions. This study design is a promising tool that can discriminate between the performance of different soft lens and multipurpose solution combinations rapidly using small patient samples. With some lens-care product combinations, corneal appearance may vary according to the time of day the patient is examined.
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Papers by Renee Garofalo